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Forehead patch may tame ADHD in autistic kids

NCT ID NCT07214545

Symptom relief Sponsor: University of California, San Francisco Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a device worn on the forehead during sleep to see if it can reduce ADHD symptoms in children with autism. About 60 children will use the device nightly for 8-12 weeks. Half will start with a real device and half with a fake one; later, those who got the fake one can try the real one. The goal is to find a safe, non-drug option to help with attention and hyperactivity.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

7 to 14 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Confirmed clinician diagnosis of ASD according to DSM-5 criteria, corroborated by prior testing (or obtained in study screening) with the Autism Diagnostic Observation Schedule (ADOS) with or without the Autism Diagnostic Interview-Revised (ADI-R) * IQ \> 70 as corroborated by prior testing (or obtained in study screening) with the Wechsler Abbreviated Scale of Intelligence Scale (WASI) * Confirmed diagnosis of ADHD according to DSM-5 criteria with minimum ADHD-RS score of \> 24 * Stable on current medications for a minimum of 4 weeks before baseline * Ability to complete protocol testing * Both the child participant and their primary caregiver must be fluent in English (speaking, reading, and understanding), as the questionnaires and assessment tools used in this study have been validated only in English. Exclusion Criteria: * Current major depression, history of psychosis, bipolar disorder, elevated risk of self-harm * History of moderate to severe coarse brain injury * Active medical illness expected to interfere with study assessments * Presence of implanted stimulator (e.g., vagal nerve stimulator) * Active dermatologic condition likely to interfere with eTNS electrode wearability * Sleep disorder likely to interfere with nightly eTNS in the opinion of the study physician * Inability to communicate discomfort or pain * Current and anticipated continued use of antipsychotic or stimulant medication

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Conditions

The condition(s) this trial relates to.

attention deficit hyperactivity disorder, inattentive type attention deficit-hyperactivity disorder autism spectrum disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Attention deficit disorder with hyperactivity (ADHD) Autism spectrum disorder (ASD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • UCSF Nancy Friend Pritzker Psychiatry Building

    RECRUITING

    San Francisco, California, 94107, United States

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Other studies related to the condition(s) this trial covers.